Comparative effectiveness of rituximab in combination with either methotrexate or leflunomide in the treatment of rheumatoid arthritis

Seminars in Arthritis and Rheumatism, 08/23/2011

Narváez J et al. – The preliminary data support the view that LEF is a useful alternative if MTX is contraindicated, since its effectiveness and safety seem similar.


  • Data from 77 consecutive unselected patients with active RA and treated with at least 1 cycle of RTX (1 g × 2 weeks) plus MTX or LEF were retrospectively collected
  • Comparative study between 2 combinations of treatment (RTX+MTX and RTX+LEF) performed at 6 months of follow-up considering 3 outcomes: improvement of RA disease activity, evolution of functional disability, and tolerability and SE profile


  • Of 77 patients, 45 received RTX+MTX and 32 RTX+LEF
  • At baseline there were no significant differences between the groups in terms of main clinical and laboratory data, or in the number of previous DMARD and anti-tumor necrosis factor agents used
  • At 6 months of follow-up, did not find significant differences between 2 combinations in evolution of RA disease activity (DAS28 response, according to European League Against Rheumatism (EULAR) improvement criteria) and functional disability progression (health assessment questionnaire) over time
  • Minor adverse events occurred in 9% of RTX+MTX patients and in 9% of RTX+LEF patients
  • None of patients had serious AEs and none discontinued treatment during study period

Print Article Summary Cat 2 CME Report